Project Determination (24ES)

STARS Tracking Number: 0900f3eb82343f5b

NCEZID Tracking Number:

040424VI

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

Primary contact

C. diff Materials Testing Research for Be Antibiotics Aware campaign
Vanessa Iheanachor

Division/Branch

DHQP/ODCO

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not require
submission to CDC’s Human Research Protection Office. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]

✔ Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.
Project is deemed not to be research under the following provision. IRB review is not required.
Select, if applicable

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this activity is to evaluate a set of draft C. difficile communications materials with
in-depth interviews with healthcare professionals (HCPs). CDC will contract KRC Research to
conduct 11 in-depth interviews with HCPs to evaluate their needs in terms of the subject and how
effective drafted communication materials are for informing HCPs on C. difficile issues. Results will
be used to improve these standard public health communications. As this activity involves the
evaluation of a standard public health program, it is consistent with non-research program
evaluation. This activity is not designed to contribute to generalizable information.
Additional considerations

Additional requirements

Changes in the nature or scope of this activity may impact the regulatory determination. Please discuss any changes with
your NC Human Subjects Advisor before they are implemented.
Reviewed by

James Peterson, PhD

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2024.04.04 12:10:06 -04'00'

Title

Human Subjects Advisor

Date 4/4/2024